Field of invention
[0001] The present invention relates to a brassiere and in particular, although not exclusively
to a brassiere having inflatable bladders to adjust a position of each breast suitable
for radiotherapy and diagnostic applications.
Background art
[0002] Breast cancer affects a substantial proportion of the population with over 1.5 million
diagnosed globally in recent years. For many of these women the primary treatment
is local excision (LE) followed by external beam radiotherapy to the whole breast.
Traditionally this has been given using basic tangential radiotherapy beams. New technology
employing complex approaches such as 3D conformal and Intensity Modulated Radiotherapy
(IMRT) provide the opportunity to spare sensitive structures that lie close to the
breast. However, such techniques require greater accuracy in patient alignment. Set
up inaccuracies (anterior-posterior and superior-inferior systematic displacements)
have dosimetric consequences that vary depending on breast gradient, standard or IMRT
based techniques and magnitude of error.
[0003] Most radiotherapy centres rely on the use of permanent tattoos marked on the patient
and use laser alignment systems. However, accuracy using this approach can be problematic
and the use of permanent tattoos is of concern to many patients. In addition, women
with large (above a D bra cup size) or pendulous breasts can be difficult to position.
Specifically, overhang of the breast inferiorly produces an effect that leads to an
increased skin dose in the lower part of the breast and on the chest wall underneath
the tissue overhang.
[0004] The long-term effects of incidental cardiac irradiation during breast radiotherapy
have been assessed and studies have indicated that while modern radiotherapy techniques
do not increase mortality from cardiac irradiation, the impact of cardiac morbidity
on breast cancer survivors is a concern. In order to reduce the dose to the heart
many centres are employing cardiac avoidance techniques including voluntary deep inspiration
breath hold (vDIBH) which has been shown to reduce mean heart dose by approximately
50%. However, using vDIBH techniques adds further opportunity for patient movement
during the beam on time and requires imaging (adding additional radiation dose to
the patient) to ensure accuracy especially in the caudo-cephalic direction where mean
systematic error in heart position of 0.5cm have been reported.
[0005] Additionally, clinical trials testing partial organ techniques compared with whole
breast irradiation (eg IMPORT low trial) in cases where there is low risk of tumour
recurrence are starting to present their results. The principle of partial breast
irradiation is to spare sensitive tissues by reducing the volume of breast tissue
irradiated. However, partial organ techniques require accurate positioning if favourable
cosmetic outcomes and local control are to be achieved. Many centres are employing
image-guided radiotherapy (IGRT) as a way of confirming radiotherapy field placement
prior to treatment exposure. However IGRT incorporates kilovoltage imaging that increases
the patient total body radiation dose received and for younger women there is concern
that the life time additional risk from this extra exposure to the contra-lateral
breast could increase the likelihood of a second cancer. Additionally, in the majority
of radiotherapy centres worldwide women lie for breast irradiation, bare from the
waist upwards, with up to four potentially male therapy radiographers adjusting and
manipulating their thorax and breast in preparation for treatment.
[0006] A number of attempts have been made to support the breast for radiotherapy treatment
and examples are described in
US 8,753,171;
US 8,814,774;
US 5,769,779;
US 2013/0316616; and
WO 2010/078048. However, existing breast manipulation garments are not optimised to stabilise the
breast whilst manipulating the breast tissue into a position that optimises the radiotherapy
treatment or diagnostic assessment whilst minimising radiation exposure to the contra-lateral
breast. Accordingly, there is a need for a breast immobilisation and positioning device
that addresses these problems.
[0007] CN 201 718 489 U discloses brassieres which have two independently inflatable bladders within a bra
cup which can be inflated to adjust the breast tissue position.
Summary of the Invention
[0008] It is an objective of the present invention to provide a breast immobilisation and
positioning device configured to lift a breast for a treatment or diagnostic investigation
whilst reducing the radiation dose to primary organs such as the heart and lung. It
is a further specific objective to provide a wearable garment configured to support
a first breast to undergo treatment or diagnosis and to minimise, as far as possible
radiation exposure to a contra-lateral breast. It is a yet further specific objective
to minimise undesirable compression, folding or wrinkling of the breast tissue whilst
the breast is lifted upwardly and away from the thoracic cage for treatment or diagnosis.
[0009] It is yet a further objective to provide a garment that may be initially calibrated
so as to be tailored to the body and breast shape (including the breast type, position
etc) that may be worn conveniently as an undergarment and is capable of remaining
in position during radiotherapy and diagnostic sessions. It is a further specific
objective to provide a garment capable of being initially positionally adjustable
to obtain a desired positioning of the breasts and then to provide positional repeatability
as the garment is removed and re-worn during repeated treatment and/or diagnostic
sessions.
[0010] The objectives are achieved by providing a brassiere having breast cups configured
with inflatable bladders specifically positioned and configured to manipulate the
breast tissue into a lifted treatment/analysis position whilst simultaneously displacing
laterally sideways/outward and downward the untreated contra-lateral breast. In particular,
the inventors provide a brassiere configured to lift the breast away from the chest
wall and to stabilise the breast so as to increase treatment accuracy and reduce radiation
dosage to high risk organs such as the heart and lung. The brassiere according to
the subject invention is advantageous to be worn by women for the treatment of either
the left or right breast whilst providing modesty during treatment delivery.
[0011] According to a first aspect of the present invention there is provided a brassiere
comprising: at least one cover layer having a pre-formed shape defining a pair of
breast cups, the cover layer at the region of each breast cup having an upper region
for positioning at or towards the clavicle of a person, a medial inner region for
positioning at or towards the sternum, a lower region for positioning at or towards
the inframammary fold of a breast, a lateral region for positioning at or towards
the serratus anterior and a central region for positioning generally at the nipple;
an inflatable main bladder positioned respectively behind the cover layer at each
cup, the main bladder extending along the lower region from the medial region to the
lateral region of each cup; the main bladder having an inlet port to allow an inflation
fluid to be introduced into the main bladder to lift the breast against gravity; a
second breast movement component positioned respectively at each breast cup at the
upper region and the medial inner region configured to move the breast laterally outward
from the inner region in an orientation towards the lateral region; wherein the main
bladder of a first cup of the pair of cups is configured to lift a first breast against
gravity and second movement component of a second cup of the pair of cups is configured
to move a second breast in the direction towards the lateral region and away from
the first breast.
[0012] Advantageously, either the left or right breast cup main bladder may be inflated
immediately prior to radiotherapy treatment according to specific desired levels to
optimise breast positioning within and outside the radiotherapy beam. The second breast
movement component is advantageous to press the non-treated (contra-lateral) breast
out of the radiotherapy beam so as to reduce radiation exposure.
[0013] The inflatable main bladders are configured by their shape profile (in particular
the pre-formed shaped of each cup) and relative positioning at the bra so as to be
complementary to the curvature of breast tissue and to provide a universal garment
suitable for a range of patient and breast sizes and shapes. In particular, the main
bladders extend and protrude beyond the
'footprint' of the breast tissue (and in particular beyond the inframammary fold) to ensure a
smooth and even breast lift and shaping of the breast tissue from the lower chest
to the breast once a bladder is inflated. Additionally, the main bladders are shaped
to conform to the contours of the brassiere cup and are co-located within the structure
of the garment so as to be formed integrally. Optionally, each bladder is formed from
an elastic or semi-elastic material such as a nitrile or polyurethane material to
provide a fluid tight chamber configured to receive the inflation fluid. Preferably,
each main bladder may be capable of elongating, stretching and generally changing
shape from an uninflated to inflated shape profile in order to adjust the breast to
a desired position and shape suitable for treatment.
[0014] Optionally, each main bladder may be connectable to a pump via a one way valve. The
bladders may be inflated during or immediately before radiotherapy treatment to a
level predetermined to achieve optimum breast tissue positioning via computerised
tomography (CT) planning undertaken as part of an initial calibration and setting
stage of the radiotherapy. Each main bladder is capable of being filled completely
or partially with an inflation fluid (typically a gas and preferably air) resulting
in the lifting and partial centralising of breast tissue.
[0015] Preferably, each port of the main bladder is positioned at or towards the lateral
and lower regions to encourage fluid to fill each bladder from the lateral and lower
regions respectively towards the medial inner region. Preferably, each inlet port
of the main bladders comprises a respective valve that is operable to open and close
independently.
[0016] Preferably, the main bladders are positioned at each breast cup to encompass the
inframammary fold of each breast. In particular, the main bladders are positioned
to extend below each breast cup and in particular below the inframammary fold of the
breast so as to ensure the breast is lifted appropriately and to avoid tissue wrinkling,
creasing or folding which would otherwise be detrimental to treatment and potentially
damaging to surrounding skin, tissue and organs. Optionally, the main bladders extend
below the breast cups such that between 1 to 10% of a volume of each main bladder
extends below each breast cups. The brassiere comprising breast cups is advantageous
in that the cups facilitate the transition of the breast tissue from the region of
the upper abdomen and through the inframammary fold region to prevent indentation,
rippling or other undesirable perturbation of the tissue with inflation of the respective
bladder.
[0017] Preferably, the cover layer is a four-piece structure having a left and right hand
side part with each part having an inner and an outer layer. Preferably, each inner
and outer layer (of each right and left side) is formed from a single fabric sheet
to reduce joining, stitching, seam and fabrication details. Reduced fabrication detail
reduces incidence of pressure lines and joint loadings on breast tissues and garment-to-tissue
rubbing. Reduced fabrication details (seams and part joint lines) further reduces
negative effects on the breast outline that may be detrimental to optimise distribution
of the radiation dose within the breast. Preferably, the material of the cover layer
is flexible but of sufficient rigidity. Such a configuration is advantageous to create
and maintain a curved cup shape from a heat pressing process in which the initial
sheet-like material is deformed by hot tool pressing. The cover layer is preferably
made from a compliant material such that the cups are capable of deforming enough
to both encapsulate and change shape to conform to the breast volume whilst supporting
and shaping the breast. Preferably, each cup extends upwards towards and over the
upper breast; sideways towards the underarm area (wing) and downwards beyond the inframammary
fold.
[0018] Preferably, the cover layer extends below the lower region of each respective cup
and the inframammary fold and comprises a lower support region being non-profiled
relative to the cups to extend laterally outward from respective sides of the xiphisternum.
The cover layer extends from the primary region of the breast and beyond the inframammary
fold towards or at a region of the upper abdomen. In particular, the lower support
region may extend below the cups by a distance in the range 1 mm to 100 mm or more
preferably by a distance of at least 10 mm, 20 mm, 30 mm, 40 mm or preferably in a
range 40 to 100 mm, 40 to 80 mm, 40 to 70 mm and more preferably 50 to 70 mm.
[0019] Preferably, the lower support region comprises an aperture positioned centrally between
and below the pair of cups so as to not cover the xiphisternum. Such an arrangement
is advantageous to allow a healthcare practitioner (therapeutic radiographer/radiation
therapist) to visualise and physically confirm the desired positioning of the garment
in relation to the xiphoid/xiphisternal joint. Optionally, the brassiere may comprise
laser registration markers of an adequate size to further assist in correct positioning
of the brassiere and patient immediately prior to therapy or diagnosis. For example,
such laser registration markers may comprise a marker placed at various regions on
the brassiere including in particular the central region (between the breast cups,
at the breast cups, at a lateral side region laterally beyond the breast cups, and
at the lower support region of the cover layer).
[0020] Preferably, each secondary breast movement component comprises a secondary bladder
having an inlet port to allow an inflation fluid to be introduced into each respective
secondary bladder. Preferably, each secondary bladder comprises the same material
composition and inlet port arrangement as described with reference to the main bladder.
In particular and preferably each secondary bladder comprises a respective valve that
is operable to open and close independently. Preferably, each valve of the main and
secondary bladders is operable to open and close independently of one another.
[0021] Optionally, the secondary breast movement component may comprise strapping, a cover,
pad or layer material removably attachable at the cover layer. Optionally, the secondary
breast movement component comprises straps having hook or loop fastenings engageable
with corresponding loop or hook fastenings provided at the cover layer. Accordingly,
the straps or pads may be adhered onto the outside surface region of the cover layer
at the upper medial inner region of the cover layer. Optionally, the majority of the
cover layer at each breast cup may comprise hook and loop fastenings or may comprise
a material attached to the cover layer comprising hook and loop fastenings to cooperate
with respective straps, pads or additional layers of material to provide the compression
and laterally outward manipulation of the breast tissue. Optionally, these straps
may comprise a length in a range 50 to 150 mm and a width in a range 10 to 150 mm.
[0022] Preferably, each inlet port of each secondary bladder is positioned respectively
at the medial inner region to encourage fluid to flow into each secondary bladder
from the medial inner region laterally outwardly towards the lateral region.
[0023] Optionally, an upper generally central region of each main bladder is positioned
generally at a central region of each breast cup at the region of the nipple. Optionally,
lateral regions of each main bladder are positioned uppermost relative to respective
medial inner regions of each main bladder.
[0024] Preferably, the cover layer is divided at a position between the pair of cups and
comprises a separable seam having respective fastenings to allow the brassiere to
be fastened in position over the breast and to be removed via the seam. Preferably,
the frontal separable seam comprises hook and eye fasteners extending along the length
of the seam located at a central region of the brassiere between the breast cups that
may be referred to as a
'gore'. The separable seam provides a front opening brassiere configuration to facilitate
daily placement and removal of the garment. Such an arrangement also enables patients
experiencing reduced mobility and movement to fit the brassiere without or with limited
assistance. Preferably, the hook and eye fasteners are formed from a material such
as a plastic that does not interfere with the analysis (such as imaging) or treatment
of the breast via radiation based techniques including for example X-ray imaging and
radiation beams.
[0025] Preferably, the brassiere comprises shoulder straps to allow the brassiere to extend
over the clavicle and around a patient's back. The brassiere also further comprises
'
wing' sections and/or straps to extend laterally around the torso of a patient from the
serratus anterior and around the patient's back. Preferably, the straps and wings
sections are formed from an elastic material and comprise fastenings (e.g. hook and
eye, poppers and the like) suitable for securing the brassiere in position during
an initial fitting session. As before, such components of the brassiere are formed
from non-metal materials to avoid interference with imaging or radiation beams. The
present garment is intended such that the shoulder straps and wing sections, once
coupled together via their respective fastenings, are not released or detached with
the brassiere being fitted and removed subsequently by a patient via the frontal seam.
Brief description of drawings
[0026] A specific implementation of the present invention will now be described, by way
of example only, and with reference to the accompanying drawings in which;
Figure 1 is a front perspective view of a brassiere having a pair of breast cups configured
with inflatable bladders according to a specific implementation of the present invention;
Figure 2 is a partial exploded view of the brassiere of figure 1;
Figure 3 is a cross sectional view through A-A of figure 1;
Figure 4 is a magnified perspective view of one of the breast cups of figure 1;
Figure 5 illustrates schematically a brassiere of figure 1 worn in position by a patient,
Detailed description of preferred embodiment of the invention
[0027] Referring to figures 1 and 2, a brassiere (bra) 10 comprises a pair of breast cups
indicated generally by reference 12. Each breast cup is defined by a cover material
or layer 11 formed from a fabric having a shape memory characteristic. In particular,
the fabric material of cover layer 11 is formed as a sheet that via a process of thermal
pressing is capable of being deformed to form the two curved breast cups 12 which
hold the respective shape configurations by virtue of such thermal pressing. Cover
layer 11 is formed from a material having a sufficient stiffness so as to provide
structural support to the breast and prevent undesirable breast movement once the
bra 10 is secured in position at a patient. Referring to figures 1 and 2, cover layer
11 according to the specific implementation is formed from two separate single pieces
11a, 11b corresponding to a left and right breast cup 12. Each cover layer piece 11a,
11b (and each corresponding breast cup 12) may be considered to be divided into different
regions relative to the anatomy of a patient and the general position of the cups
12 as they support each breast.
[0028] Referring specifically to figures 2 and 3, the bra 10 at the region of each breast
cup 12 is formed as a multilayer structure in which the cover layer 11 represents
an outward orientated part of the bra 10. The bra 10 also comprises an inward facing
comfort layer 30 extending immediately behind cover layer 11. Comfort layer 30 is
formed from a softer, more deformable material than the shape memory cover layer 11
such that comfort layer 30 is configured to conform to the pre-formed curved shape
of each cover layer piece 11a, 11b. Each layer 30 (of the left and right hand side
sections) is formed from a single piece material to provide a simplified construction
which is advantageous to reduce the risk of breast tissue wrinkling or creasing resulting
from seams, sticking etc., as the bra 10 is actuated to manipulate the tissue in use.
For illustrative convenience, and with reference to the left and right breasts comfort
layers 30a, 30b, each comfort layer piece 30a, 30b and accordingly each cover layer
piece 11a, 11b (cup 12) comprises generally a lower region 39, 40 and an upper region
37, 38. Each cup cover layer piece 11a, 11b is formed from a single fabric sheet to
reduce joining, stitching, seam and fabrication details that may otherwise create
pressure lines and point loadings on breast tissue. Such single piece components 11a,
11b reduce the opportunity for pressure sores and garment to tissue rubbing and accordingly
increase patient comfort. Reduced fabrication details (seams and part join lines)
further reduce negative effects on breast outline that may affect the ability to produce
an acceptable radiation dose distribution within the breast Each of these upper and
lower regions may be divided further into a respective medial inner region 37, 40
and a lateral region 38, 39. Accordingly, each cover layer piece 11a, 11b (cup 12)
may be divided into an upper medial inner region 37; a lower medial inner region 40;
a lateral lower region 39 and a lateral upper region 38. Each region 37 to 40 extends
respectively from a perimeter of each cover layer piece 11a, 11b to a central innermost
region 41 that corresponds generally to a central position of each breast cup 12 to
be positioned over a breast nipple. The upper medial inner region 37 is configured
for positioning towards an upper part of the sternum 66 and the lower medial inner
region 40 is configured for positioning towards a lower region of sternum 66 and in
particular the xiphisternum 61. Lateral lower region 39 is configured for positioning
at or towards the serratus anterior 62 whilst upper lateral region 38 is configured
for positioning towards the pectoralis minor. Upper lateral region 38 is provided
to extend in close fitting contact to the junction of the torso and arm union (underarm)
to cover and encapsulate tissue at a 'breast tail' (breast tissue in the area of the
underarm) and to provide a patient 'snug-fit' that in turn reduces or eliminates the
occurrence of the breast tissue bulging over from the outermost lateral edge of the
garment 10.
[0029] Additionally, the upper regions 37 and 38 taper upwardly to form a base part 36 of
shoulder straps 16 to extend over the shoulders and around the back of a patient.
In particular strap base part 36 is configured for positioning over the clavicle 63.
Each regions 37 to 40 of cover layer pieces 11a, 11b are curved to collectively define
the each breast cups 12 that extends over all regions all regions 37 to 40 and central
region 41. A lowermost section of lower regions 39, 40 is non-profiled (relative to
the majority of the curved breast cup 12) and is formed as a generally flat band that
extends from the lower medial inner region (at the xiphisternum 61) to the lower lateral
region (at the serratus anterior 62). This band region is referred to generally as
reference 15 and comprises a width (in a direction perpendicular to a lateral direction
between the xiphisternum 61 and the serratus anterior 62), that is in a range 40 to
80 mm so as to extend a sufficient distance below the inframammary fold indicated
generally by reference 45 referring to figure 5. Such a configuration is advantageous
to ensure the breast tissue is encapsulated fully and to securely position and mount
the bra 10 at a patient. Accordingly, the bra 10 is configured to surround a reasonable
portion of a person's upper abdomen indicated generally by reference 60 and to extend
onto the upper region of the rectus abdominis. The cover layer at each respective
lower medial inner region 40 comprises a notch such that when the pieces 11a, 11b
are coupled together to form bra 10, an opening or aperture 24 is defined to expose
the xiphisternum. Such an arrangement is advantageous to allow medical staff to identify
the correct positioning of the bra 10 at a patient by reference to the xiphisternum.
[0030] Each strap base part 36 mounts a corresponding clip or buckle 23 to receive respectively
each strap 16 being conventional to the majority of bras, with each strap 16 comprising
suitable adjustable fastenings 17. Each cover layer piece 11a, 11b comprises a lateral
end edge 70. Bra 10 further comprises a pair of wings indicated generally by reference
42 that project laterally outward from each edge 70 with each wing 42 being formed
from a material different to cover layer 11. Each wing 19 is terminated at its laterally
outermost end by a respective elasticated strap 19 formed from a material different
to wings 19 and cover layer 11, with each strap 19 configured to extend around the
back of a person according to conventional bra configurations. According to the specific
implementation, an elasticity of each of the wing 42 and each strap 19 is greater
than that of each cover layer piece 11a, 11b such that in combination with straps
16, straps 19 are capable of securing the bra 10 in position at a person. Each strap
19 accordingly comprises releasable attachments 20 according to conventional configurations.
Advantageously, the present bra 10 comprises a third releasable fastening in the form
of a central seam indicated generally by reference 20 that extends in the upward and
downward direction between the breast cups 12 so as to couple each cover layer piece
11a, 11b. Seam 20 comprises a first part 20a and a second part 20b, with each part
comprising respective fastenings 21 to allow each seam part 20a, 20b to be releasably
coupled together so as to provide a front opening bra arrangement. Accordingly, bra
10 is configured to be
'fitted' to a person via an initial fitting and calibration stage, supervised by medical staff,
to ensure bra 10 is appropriately adjusted such that the breasts are fully encapsulated
within each breast cup 12 to the desired degree and in particular cover layer pieces
11a, 11b encapsulate the inframammary fold region 45 as desired. A person may then
conveniently mount and remove the bra 10 via the releasable central seam 20. Further
positioning and alignment verification is achieved by bra 10 comprising laser markers
22a located within lower lateral region 35 of each cover piece 11a, 11b and respective
laser markers 22b provided at seam 20. Optionally, each cover layer piece 11a, 11b
comprises a material that may be marked by a fabric pen or similar during an initial
set-up or planning stage with such custom marking being identifiable during subsequent
treatment/diagnostic sessions.
[0031] Each left and right hand set of layers 11 and 30 are secured in position by an upper
seam 43 and a lower seam 44 extending respectively above and below each breast from
the medial inner to the lateral outer regions. A pocket region 32 is defined between
respective inward facing surfaces 33 and 34 of the outer and inner layers 11 and 30.
A main inflatable bladder 13 having an internal chamber 31 is housed within each left
hand and right hand pocket 32. Additionally, each pocket 32 accommodates a secondary
bladder 14 (not shown in figure 3) such that each breast cup comprises a primary main
bladder 13 and a secondary bladder 14. Each bladder 13, 14 may be secured in position
within each pocket 32 by stitching or spot welds (not shown) provided respectively
between each bladder 13, 14 and layer 11 and/or layer 30.
[0032] Each bladder 13, 14 is formed from an elastic stretchable material such as a polyurethane
or nitrile material and is capable of elongating and stretching in response to an
inflation fluid being introduced respectively into each bladder 13, 14 as desired.
Each main bladder 13 is positioned within each pocket 32 so as to extend from the
medial inner region to the lateral region extending over predominantly lower regions
40, 39 and central region 41. In particular, each main bladder 13 may be regarded
as extending over a lower region of each breast cup 12 so as to extend from the region
of the breast nipple to below the inframammary fold and onto the region of strap or
band 15 extending laterally to each side of the xiphisternum.
[0033] Referring to figure 4, each main bladder 13 may be divided for illustrative purposes
only into four zones including an upper medial inner zone 13b; a lower medial inner
zone 13c; a lower lateral zone 13d and an upper lateral zone 13a. Each bladder 13
extends substantially the full lateral width of breast cup 12 and comprises an first
innermost end 46 located a short distance laterally to the side of central seam 20
at the region of the sternum 66 and a second lateral outer end 49 positioned at the
lateral outermost side of the breast cup 12 at the region of the serratus anterior.
Additionally, a lower region 48 (or curved edge region) of each bladder 13 extends
below the inframammary fold 45 and in particular below the curvature of each cup 12
such that the bladder lower region 48 is positioned at the non-profiled band 15. Lower
region 48 (below breast cup 12) extends over a distance in the range 50 to 95% of
the full width (in the lateral direction) of each breast cup 12 so as to encapsulate
substantially all of the inframammary fold 45. Accordingly, each main bladder 13 is
positioned generally to extend across the full width of each breast cup 12 (at a lower
region of each cup 12) so as to be capable of lifting the entire breast tissue when
each bladder 13 is inflated. Encapsulating the inframammary fold 45 is advantageous
to avoid trapping, rippling, wrinkling or otherwise distorting the breast tissue (during
bladder inflation) which will be disadvantageous for therapy and diagnosis specifically
with regard to radiation exposure. Additionally, to achieve the desired lifting and
centralising of the breast tissue, and to further reduce the likelihood of undesirable
tissue rippling or trapping, an uppermost part 50 of the second lateral outer end
49 of bladder 13 is positioned above (or higher than) a corresponding uppermost part
51 of the first innermost end 46. Accordingly, each bladder 13 may be perceived to
be inclined to taper downwardly from its lateral outermost end 49 to its innermost
end 46 such that an upper region (or curved upper edge 47) of each bladder 13 slopes
downwardly from the pectoralis minor to the sternum 66.
[0034] Each secondary bladder 14 is positioned generally at an upper medial inner region
of each breast cup 12 (and each cover layer piece 11a, 11b) so as to project upwardly
and laterally outward from the region of central seam 20 and the sternum 66. That
is, each secondary bladder 14 is intended to extend over the upper inner region of
each breast so as to provide a very different breast manipulation function to that
of the primary bladders 13. Referring to figure 4, each secondary bladder 14 comprises
an outermost lateral end 52 positioned within the medial inner region 37 of each cover
layer piece 11a, 11b and a lateral inner end indicated generally by reference 71 positioned
in close proximity to central seam 20 substantially at sternum 66. Each secondary
bladder 14 also comprises an upper region 53 positioned immediately below upper seam
43 and a lower region 54 positioned immediately above central region 41. In particular,
each bladder 14 extends almost exclusively within the upper medial inner region 37
of each cover piece 11a, 11b and is positioned generally above and to the medial inside
of central region 41.
[0035] Each respective bladder 11, 14 comprises a respective inlet port in the form of an
elongate tube formed as an extension of each bladder and preferably from the same
elastic stretchable material. The inlet tubes 18 of the main bladder 13 are positioned
at the lower lateral sides of each bladder 13 so as to extend from the region below
the inframammary fold 45 (at the junction of the curved breast cup 12 and the non-profiled
band 15). Each tube 18 extends within the same pocket 32 that accommodates the bladders
13 and 14. A small slit or opening (not shown) is provided within either of the layers
11, 30 from which an endmost part of each tube 80 projects. Each of the secondary
bladders 14 comprises a corresponding fluid inlet tube 25 extending within each pocket
32. Each secondary inlet tube 25 is positioned at the respective lateral side of central
seam 20 to extend from each secondary bladder 14 at its respective medial inner end
71. Each tube 18, 25 accordingly defines fluid inlets 56, 55 at each bladder 13, 14
respectively. The main bladder inlet 56 is positioned below inframammary fold 45 at
the lower lateral region of each cover layer piece 11a, 11b. Additionally, the secondary
bladder inlet 55 is positioned at the medial inner end 71 immediately laterally to
the side of the central seam 20. A respective valve 26 is mounted at each end of each
tube 18, 25. Each valve 26 is connectable to a suitable supply reservoir 29 (such
as a pump, syringe, canister, or other fluid vessel) via a gauge 28 and hose 27 so
as to allow each respective left and right hand main and secondary bladder 13, 14
to be inflated independently. That is, each of the four bladders 13, 14 may be inflated
independently of one another by coupling to a single common pump 29 via valves 26.
[0036] Referring to figure 5, bra 10 via the respective bladders 13, 14 provides a medical
garment configured for the asymmetric manipulation of the left and right hand breasts
to suit the radiotherapy or diagnostic imaging of the appropriate breast. By providing
both left and right hand main and secondary bladders 13, 14, bra 10 is symmetrically
constructed to provide a universal garment within which selected bladders may be inflated
to achieve appropriate lifting or compression (and lateral sideways deflection) of
the relevant breast. Referring to figure 5, a patient requiring radiotherapy treatment
of a left breast 67b would require inflation of the corresponding left bladder 13.
Due to the relative position of fluid inlet 56 (located at the lateral and lower region
of cover piece 11b at the main bladder zone 13d) the inflation fluid (air) is configured
to flow upwardly (indicated by arrows 64) and towards the medial inner region so as
to provide a lifting and centralising manipulation of the left breast 67b. To reduce
radiation exposure to the contra-lateral right breast 67a, the right hand secondary
bladder 14 is inflated via introduction of air at inlet 55. This provides a corresponding
laterally outward compressive manipulation of the right breast 67a as indicated by
arrows 65. That is, the tissue of breast 67a is forced and compressed laterally outward
from an upper region of the sternum 66 (cup region 37) towards a lateral portion of
the inframammary fold 45 (cup region 39). This action also increases the volume of
breast tissue at and below the inframammary fold 45. Accordingly, the tissue of the
contra-lateral breast 67a is moved away from the radiative treatment zone of breast
67b. For the purposes of clarity, to achieve the lifting and compression of the respective
breasts 67b and 67a, (as shown in figure 5), the main bladder 13 at the right hand
breast 67a and the secondary bladder 14 at left hand breast 67b are dormant (uninflated).
1. A brassiere (10) comprising:
at least one cover layer (11) having a pre-formed shape defining a pair of breast
cups (12), the cover layer at the region of each breast cup having an upper region
(37, 38) for positioning at or towards the clavicle of a person, a medial inner region
for positioning at or towards the sternum, a lower region (39, 40) for positioning
at or towards the inframammary fold of a breast, a lateral region (70) for positioning
at or towards the serratus anterior and a central region (41) for positioning generally
at the nipple;
an inflatable main bladder (13) positioned respectively behind the cover layer at
each cup, the main bladder extending along the lower region from the medial region
to the lateral region of each cup;
the main bladder having an inlet port (18) to allow an inflation fluid to be introduced
into the main bladder to lift the breast against gravity;
a second breast movement component (14) positioned respectively at each breast cup
at the upper region and the medial inner region configured to move the breast laterally
outward from the inner region in an orientation towards the lateral region;
wherein the main bladder of a first cup of the pair of cups is configured to lift
a first breast against gravity and characterized in that the second movement component of a second cup of the pair of cups is configured to
move a second breast in the direction towards the lateral region and away from the
first breast.
2. The brassiere as claimed in claim 1 wherein each port of the main bladder (13) is
positioned at or towards the lateral and lower regions to encourage fluid to fill
each bladder from the lateral and lower regions respectively towards the medial inner
region.
3. The brassiere as claimed in claims 1 or 2 wherein each inlet port of the main bladders
each comprise a respective valve (26) that is operable to open and close independently.
4. The brassiere as claimed in any preceding claim wherein the main bladders (13) are
positioned at each breast cup to encompass the inframammary fold (45) of each breast.
5. The brassiere as claimed in any preceding claim wherein each secondary breast movement
component comprises a secondary bladder (14) having an inlet port (25) to allow an
inflation fluid to be introduced into each respective secondary bladder.
6. The brassiere as claimed in claim 5 wherein each secondary bladder (14) comprises
a respective valve (26) that is operable to open and close independently.
7. The brassiere as claimed in claim 6 wherein each valve (26) of the main and secondary
bladders is operable to open and close independently of one another.
8. The brassiere as claimed in any one of claims 5 to 7 wherein each inlet port (55)
of each secondary bladder is positioned respectively at the medial inner region to
encourage fluid to flow into each secondary bladder from the medial inner region laterally
outwardly towards the lateral region.
9. The brassiere as claimed in any preceding claim wherein the cover layer (11) of each
breast cup comprises a single piece material.
10. The brassiere as claimed in any preceding claim wherein the cover layer extends below
the lower region of each respective cup (12) and the inframammary fold (45) and comprises
a lower support region (15) being non-profiled relative to the cups to extend laterally
outward from respective sides of the xiphisternum (61).
11. The brassiere as claimed in claim 10 wherein the lower support region (15) extends
below the cups by a distance of at least 40 mm.
12. The brassiere as claimed in claim 10 wherein the lower support region (15) extends
below the cups by a distance in a range 40 to 80 mm.
13. The brassiere as claimed in any one of claims 10 to 12 wherein the lower support region
comprises an aperture (24) positioned centrally between and below the pair of cups
so as to not cover the xiphisternum.
14. The brassiere as claimed in any preceding claim wherein an upper generally central
region of each main bladder (13) is positioned generally at a central region of each
breast cup at the region of the nipple.
15. The brassiere as claimed in any preceding claim wherein:
lateral regions (13a, 13d) of each main bladder are positioned uppermost relative
to respective medial inner regions (13b, 13c) of each main bladder; and/or
the cover layer is divided at a position between the pair of cups and comprises a
separable seam (20) having respective fastenings (21) to allow the brassiere to be
fastened in position over the breast and to be removed via the seam.
1. Büstenhalter (10), umfassend:
mindestens eine Deckschicht (11), die eine vorgebildete Form aufweist, die ein Paar
Brustschalen (12) definiert, wobei die Deckschicht in dem Bereich jeder Brustschale
einen oberen Bereich (37, 38) zum Positionieren an der Clavicula einer Person oder
zu dieser hin, einen mittleren inneren Bereich zum Positionieren am Sternum oder zu
diesem hin, einen unteren Bereich (39, 40) zum Positionieren an der Unterbrustfalte
einer Brust oder zu dieser hin, einen seitlichen Bereich (70) zum Positionieren am
Musculus serratus anterior oder zu diesem hin und einen zentralen Bereich (41) zum
Positionieren im Allgemeinen an der Brustwarze aufweist;
eine aufblasbare Hauptblase (13), die jeweils hinter der Deckschicht an jeder Schale
angeordnet ist, wobei sich die Hauptblase entlang des unteren Bereichs von dem mittleren
Bereich zu dem seitlichen Bereich jeder Schale erstreckt;
wobei die Hauptblase eine Einlassöffnung (18) aufweist, um es zu ermöglichen, dass
ein Aufblasfluid in die Hauptblase eingeführt werden kann, um die Brust gegen die
Schwerkraft zu heben;
eine zweite Brustbewegungskomponente (14), die jeweils an jeder Brustschale am oberen
Bereich und am mittleren inneren Bereich angeordnet ist und die dazu konfiguriert
ist, die Brust seitlich nach außen von dem inneren Bereich in einer Ausrichtung zu
dem seitlichen Bereich hin zu bewegen;
wobei die Hauptblase einer ersten Schale des Schalenpaars dazu konfiguriert ist, eine
erste Brust gegen die Schwerkraft zu heben, und dadurch gekennzeichnet, dass die zweite Bewegungskomponente einer zweiten Schale des Schalenpaars dazu konfiguriert
ist, eine zweite Brust in der Richtung zum seitlichen Bereich und von der ersten Brust
weg zu bewegen.
2. Büstenhalter nach Anspruch 1, wobei jede Öffnung der Hauptblase (13) an dem oder zu
dem seitlichen und dem unteren Bereich hin angeordnet ist, um es dem Fluid zu erleichtern,
jede Blase von dem seitlichen und dem unteren Bereich aus jeweils zu dem mittleren
inneren Bereich hin zu füllen.
3. Büstenhalter nach den Ansprüchen 1 oder 2, wobei jede Einlassöffnung der Hauptblasen
jeweils ein entsprechendes Ventil (26) umfasst, das so betrieben werden kann, dass
es sich unabhängig öffnet und schließt.
4. Büstenhalter nach einem der vorstehenden Ansprüche, wobei die Hauptblasen (13) an
jeder Brustschale so angeordnet sind, dass sie die Unterbrustfalte (45) jeder Brust
umfassen.
5. Büstenhalter nach einem der vorstehenden Ansprüche, wobei jede sekundäre Brustbewegungskomponente
eine sekundäre Blase (14) umfasst, die eine Einlassöffnung (25) aufweist, um es zu
ermöglichen, dass ein Aufblasfluid in jede entsprechende sekundäre Blase eingeführt
werden kann.
6. Büstenhalter nach Anspruch 5, wobei jede sekundäre Blase (14) ein entsprechendes Ventil
(26) umfasst, das so betrieben werden kann, dass es sich unabhängig öffnet und schließt.
7. Büstenhalter nach Anspruch 6, wobei jedes Ventil (26) der Haupt- und der sekundären
Blase so betätigt werden kann, dass es sich unabhängig von dem jeweils anderen öffnet
und schließt.
8. Büstenhalter nach einem der Ansprüche 5 bis 7, wobei jede Einlassöffnung (55) jeder
sekundären Blase jeweils an dem mittleren inneren Bereich angeordnet ist, um es dem
Fluid zu erleichtern, in jede sekundäre Blase von dem mittleren inneren Bereich aus
seitlich nach außen zum seitlichen Bereich hin zu strömen.
9. Büstenhalter nach einem der vorstehenden Ansprüche, wobei die Deckschicht (11) jeder
Brustschale ein einziges Materialstück umfasst.
10. Büstenhalter nach einem der vorstehenden Ansprüche, wobei sich die Deckschicht jeweils
unter den unteren Bereich jeder Schale (12) und der Unterbrustfalte (45) erstreckt
und einen unteren Stützbereich (15) umfasst, der im Verhältnis zu den Schalen unprofiliert
ist, um sich seitlich nach außen von den jeweiligen Seiten des Schwertfortsatzes (61)
zu erstrecken.
11. Büstenhalter nach Anspruch 10, wobei sich der untere Stützbereich (15) unter die Schalen
um eine Strecke von mindestens 40 mm erstreckt.
12. Büstenhalter nach Anspruch 10, wobei sich der untere Stützbereich (15) unter die Schalen
um eine Strecke in einem Bereich von 40 bis 80 mm erstreckt.
13. Büstenhalter nach einem der Ansprüche 10 bis 12, wobei der untere Stützbereich eine
Öffnung (24) umfasst, die zentral zwischen und unter dem Schalenpaar so angeordnet
ist, dass sie den Schwertfortsatz nicht bedeckt.
14. Büstenhalter nach einem der vorstehenden Ansprüche, wobei ein oberer, im Allgemeinen
zentraler Bereich jeder Hauptblase (13) im Allgemeinen an einem zentralen Bereich
jeder Brustschale im Bereich der Brustwarze angeordnet ist.
15. Büstenhalter nach einem der vorstehenden Ansprüche, wobei:
seitliche Bereiche (13a, 13d) jeder Hauptblase zuoberst im Verhältnis zu jeweiligen
mittleren inneren Bereichen (13b, 13c) jeder Hauptblase angeordnet sind; und/oder
die Deckschicht an einer Stelle zwischen dem Schalenpaar geteilt ist und eine trennbare
Naht (20) umfasst, die jeweilige Befestigungen (21) aufweist, um es zu ermöglichen,
dass der Büstenhalter in Position über der Brust fixiert und mittels der Naht entfernt
werden kann.
1. Soutien-gorge (10) comprenant :
au moins une couche de couverture (11) ayant une forme préformée définissant une paire
de bonnets (12), la couche de couverture au niveau de la zone de chaque bonnet ayant
une zone supérieure (37, 38) pour un positionnement au niveau ou en direction de la
clavicule d'une personne, une zone intérieure médiane pour un positionnement au niveau
ou en direction du sternum, une zone inférieure (39, 40) pour un positionnement au
niveau ou en direction du sillon infra-mammaire d'un sein, une zone latérale (70)
pour un positionnement au niveau ou en direction de la zone antérieure et centrale
du muscle grand dentelé (41) pour un positionnement généralement au niveau du mamelon
;
une vessie principale gonflable (13) positionnée respectivement derrière la couche
de couverture au niveau de chaque bonnet, la vessie principale s'étendant le long
de la zone inférieure depuis la zone médiane jusqu'à la zone latérale de chaque bonnet
;
la vessie principale ayant un orifice d'entrée (18) pour permettre l'introduction
d'un fluide de gonflage dans la vessie principale afin de soulever le sein en s'opposant
à la pesanteur ;
un second élément mobile (14) de sein positionné respectivement sur chaque bonnet
au niveau de la zone supérieure et de la zone intérieure médiane configuré pour déplacer
latéralement les seins vers l'extérieur depuis la zone intérieure dans une orientation
allant vers la zone latérale ;
dans lequel la vessie principale d'un premier bonnet de la paire de bonnets est configurée
pour soulever un premier sein en s'opposant à la pesanteur et, caractérisé en ce que le second élément mobile d'un second bonnet de la paire de bonnets est configuré
pour déplacer un second sein en direction de la zone latérale et à l'écart du premier
sein.
2. Soutien-gorge selon la revendication 1, dans lequel chaque orifice de la vessie principale
(13) est positionné au niveau ou en direction des zones latérale et inférieure pour
pousser le fluide à remplir chaque vessie depuis les zones latérale et inférieure
respectivement en direction de la zone intérieure médiane.
3. Soutien-gorge selon les revendications 1 ou 2, dans lequel chaque orifice d'entrée
des vessies principales comprend chacun une valve (26) respective qui peut s'ouvrir
et se fermer de façon indépendante.
4. Soutien-gorge selon une quelconque revendication précédente, dans lequel les poches
principales (13) sont positionnées au niveau de chaque bonnet pour englober le sillon
infra-mammaire (45) de chaque sein.
5. Soutien-gorge selon une quelconque revendication précédente, dans lequel chaque élément
mobile secondaire de sein comprend une vessie secondaire (14) ayant un orifice d'entrée
(25) pour permettre à un fluide de gonflage d'être introduit dans chaque vessie secondaire
respective.
6. Soutien-gorge selon la revendication 5, dans lequel chaque vessie secondaire (14)
comprend une valve (26) respective qui peut s'ouvrir et se fermer de façon indépendante.
7. Soutien-gorge selon la revendication 6, dans lequel chaque valve (26) des vessies
principale et secondaire peut s'ouvrir et se fermer indépendamment l'une de l'autre.
8. Soutien-gorge selon l'une quelconque des revendications 5 à 7, dans lequel chaque
orifice d'entrée (55) de chaque vessie secondaire est positionné respectivement au
niveau de la zone intérieure médiane pour pousser le fluide à s'écouler dans chaque
vessie secondaire depuis la zone intérieure médiane latéralement vers l'extérieur
en direction de la zone latérale.
9. Soutien-gorge selon une quelconque revendication précédente, dans lequel la couche
de couverture (11) de chaque bonnet comprend un matériau constitué d'une seule pièce.
10. Soutien-gorge selon une quelconque revendication précédente, dans lequel la couche
de couverture s'étend en dessous de la zone inférieure de chaque bonnet (12) respectif
et du sillon infra-mammaire (45) et comprend une zone de soutien inférieure (15) qui
n'est pas profilée par rapport aux bonnets pour s'étendre latéralement vers l'extérieur
depuis les côtés respectifs de la pointe du sternum (61).
11. Soutien-gorge selon la revendication 10, dans lequel la zone de soutien inférieure
(15) s'étend en dessous des bonnets sur une distance d'au moins 40 mm.
12. Soutien-gorge selon la revendication 10, dans lequel la zone de soutien inférieure
(15) s'étend en dessous des bonnets sur une distance allant de 40 à 80 mm.
13. Soutien-gorge selon l'une quelconque des revendications 10 à 12, dans lequel la zone
de soutien inférieure comporte une ouverture (24) positionnée au centre entre et en
dessous de la paire de bonnets de manière à ne pas recouvrir la pointe du sternum.
14. Soutien-gorge selon une quelconque revendication précédente, dans lequel une zone
centrale généralement supérieure de chaque vessie principale (13) est généralement
positionnée sur une zone centrale de chaque bonnet dans la zone du mamelon.
15. Soutien-gorge selon une quelconque revendication précédente, dans lequel :
les zones latérales (13a, 13d) de chaque vessie principale sont positionnées le plus
haut par rapport aux zones intérieures médianes (13b, 13c) respectives de chaque vessie
principale ; et/ou
la couche de couverture est divisée en une position entre la paire de bonnets et comporte
une couture séparable (20) ayant des attaches (21) respectives pour permettre au soutien-gorge
d'être fixé en position sur la poitrine et d'être retiré via la couture.